Achieving Stress-free Compliance for Product Claims in the United States

This is part 2 of the insights from Taking the stress out of claims in the US. Insight and content provided by Ivan Wasserman & Jennifer Adams of Amin Talati Wasserman.

Consumers are increasingly well-informed about what they eat and demanding more information about the quality and safety of the food products they purchase. 

According to the IPSOS Nutiani Consumer Wellness Research¹ ,  92% of Americans pay attention to product attributes when purchasing products to keep healthy, including health benefit claims.

Maintaining compliance in what is now a very complex regulatory landscape will not only ensure your products remain on the shelves, but also help build long-term brand credibility and consumer trust.

Supporting claims with science-backed evidence

All marketing claims must be truthful, not misleading and adequately supported. Although the Food and Drug Administration (FDA) can regulate this, a claim’s accuracy is primarily overseen by a different agency: the Federal Trade Commission (FTC).

The FTC expects health claims to be supported by ‘competent and reliable scientific evidence’, also known as CARSE. 
 

CARSE is defined as "tests, analyses, research, studies or other evidence-based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results." 

While CARSE appears to be a flexible standard, its enforcement history shows the FTC expects products that are making an unqualified structure/function claim to to be supported by at least one human clinical study that: 

• Is randomised, double-blind, and placebo-controlled;
• Is carried out on the product itself (or an ingredient in the product if other conditions are met);
• Is conducted on a population that matches the target demographic of the product;
• Is methodologically sound;
• Has statistically significant results compared to placebo; and
• Found a benefit that is clinically meaningful.

The above reflects the gold standard. That said, even studies that do not satisfy all these criteria may still play a role in substantiating a claim. Scientific evidence used to support a claim is looked at in its totality. It is possible that two or more studies that each have weaknesses may support a claim when combined. Conversely, it is possible that a claim may be rejected if a more robust study refutes its benefits.

The importance of a placebo control cannot be overstated, especially for subjective outcomes such as feelings of stress and calmness. While non-placebo-controlled studies provide helpful background information and are an important step in a clinical research plan, they are not likely to support health claims on their own. 
 

Substantiating claims

When substantiating stress-related claims, key considerations will be the population studied and assessment tools used. Subjects should ideally be people who report feeling daily stress, but not in such a way that they qualify as having a stress-related disorder. As it is challenging to objectively measure feelings of stress or calmness, any subjective assessment tool used (e.g. questionnaires) must be validated.

Additional considerations arise if the substantiation for the claim is based on an ingredient rather than the product. Brands need to ensure the study on the ingredient is CARSE and applicable to the finished product’s target market. For instance, a robust study on an ingredient that involves only male subjects may not be CARSE for a product targeting women.
 

Another common issue is underdosing. If the product is providing less of the ingredient than what was included in the study, it is unlikely to meet the CARSE standard to support the claim.

In addition, all messaging must make it clear to consumers that the ingredient is the basis of the claim (e.g. “with ingredient X, to help you relax from daily stresses”).

Finally, it is important to use only scientifically backed ingredients from reputable suppliers. They should be willing share information on the quality of their products and accompanying evidence. The FTC will insist on reviewing the studies of suppliers, so brands should do the same when deciding on the source of their ingredients. 

The main gatekeepers you need to be aware of:

The FTA and the FTC are not the only enforcers of compliance. Other regulatory groups to be aware of include:

FDA

• Primary focus is whether it is a structure / function claim
• If it is believed to be an impermissible disease claim the enforcement tools available are:
  • Publicly posted Warning Letter
  • Seizure of products
  • Enjoin companies from distributing products
  • Detain product at port of entry
  • Refuse entry at port if claims are not compliant and unable to be reconditioned

FTC

• Primary focus is claim substantiation
• Enforcement can be via a civil complaint in federal court or with an administrative judge
• Investigation is only made public if a complaint is filed or a settlement is finalised      

Competitors

• May act if they feel that a product is gaining an advantage due to a non-compliant claim
• Competitors can inform the FDA or FTC about the claim
• Alternatively, there are causes of action for unfair competition that can be pursued via the court system

Self-regulatory forum e.g., National Advertising Division (NAD)

• The NAD offers a shortened timeline to traditional litigation at a reduced cost
• Independent experts will weigh in on the accuracy of the claim
• NAD’s decisions are non-binding and do not have legal precedence, however companies tend to follow their recommendations – if they  choose not to, NAD can refer the case to the FTC or FDA

Consumer class action

• Attorneys represent consumers who allege they were deceived into purchasing a product due to misleading claims
• Damages sought after are usually a full or partial refund of purchase price to all purchasers

The good news is that well substantiated stress-related claims are possible. Vet your suppliers, assess your substantiation, and with this greater understanding of what’s required, your compliance should be stress free.

Disclaimer: The views expressed above are the opinion of the author, and Fonterra is not responsible for any decisions taken in reliance on the same.